Which AI-powered medical device became the first to receive FDA authorization for autonomous diagnosis without physician review in 2018, revolutionizing medical product development?

In recent years, artificial intelligence has dramatically transformed medical diagnostics and product development. AI-powered medical devices are rapidly changing how healthcare professionals detect diseases and recommend treatments. This trivia question tests your knowledge about a groundbreaking AI diagnostic technology that marked a significant milestone for healthcare innovation and regulatory approaches.

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IDx-DR for diabetic retinopathy detection
Eko's ECG analysis software for heart murmurs
Imagen's OsteoDetect for wrist fracture analysis
Zebra Medical's brain hemorrhage detection system